LUXEN Smile, LUXEN Zr

GUDID 08800046990868

DENTALMAX CO.,LTD

Dental appliance fabrication material, ceramic

Primary Device ID	08800046990868
NIH Device Record Key	fa4e17bd-7ac7-4219-9fad-73edc142ed97
Commercial Distribution Status	In Commercial Distribution
Brand Name	LUXEN Smile, LUXEN Zr
Version Model Number	ML 600 D95 HT 10T
Company DUNS	688528450
Company Name	DENTALMAX CO.,LTD
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800046990868 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K171585

FDA Product Code

EIH	Powder, Porcelain

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2022-02-14
Device Publish Date	2022-02-04

On-Brand Devices [LUXEN Smile, LUXEN Zr]

08800046977241	Zr-10T-D98-HT
08800119910779	ML 1200 600 Multi P D95 MHT Dark 12T
08800119910762	ML 1200 600 Multi P D95 MHT Dark 14T
08800119910755	ML 1200 600 Multi P D95 MHT Dark 16T
08800119910748	ML 1200 600 Multi P D95 MHT Dark 18T
08800119910731	ML 1200 600 Multi P D95 MHT Dark 20T
08800119910724	ML 1200 600 Multi P D95 MHT Dark 22T
08800119910717	ML 1200 600 Multi P D95 MHT Dark 25T
08800119910700	ML 1200 600 Multi P D95 MHT Dark 28T
08800119910694	ML 1200 600 Multi P D95 MHT Dark 30T
08800119910687	ML 1200 600 Multi P D95 MHT Light 12T
08800119910670	ML 1200 600 Multi P D95 MHT Light 14T
08800119910663	ML 1200 600 Multi P D95 MHT Light 16T
08800119910656	ML 1200 600 Multi P D95 MHT Light 18T
08800119910649	ML 1200 600 Multi P D95 MHT Light 20T
08800119910632	ML 1200 600 Multi P D95 MHT Light 22T
08800119910625	ML 1200 600 Multi P D95 MHT Light 25T
08800119910618	ML 1200 600 Multi P D95 MHT Light 28T
08800119910601	ML 1200 600 Multi P D95 MHT Light 30T
08800119910595	ML 1200 600 Multi P D95 MHT Medium 12T
08800119910588	ML 1200 600 Multi P D95 MHT Medium 14T
08800119910571	ML 1200 600 Multi P D95 MHT Medium 16T
08800119910564	ML 1200 600 Multi P D95 MHT Medium 18T
08800119910557	ML 1200 600 Multi P D95 MHT Medium 20T
08800119910540	ML 1200 600 Multi P D95 MHT Medium 22T
08800119910533	ML 1200 600 Multi P D95 MHT Medium 25T
08800119910526	ML 1200 600 Multi P D95 MHT Medium 28T
08800119910519	ML 1200 600 Multi P D95 MHT Medium 30T
08800119910502	ML 1200 600 Multi P D98 MHT Dark 12T
08800119910496	ML 1200 600 Multi P D98 MHT Dark 14T
08800119910489	ML 1200 600 Multi P D98 MHT Dark 16T
08800119910472	ML 1200 600 Multi P D98 MHT Dark 18T
08800119910465	ML 1200 600 Multi P D98 MHT Dark 20T
08800119910458	ML 1200 600 Multi P D98 MHT Dark 22T
08800119910441	ML 1200 600 Multi P D98 MHT Dark 25T
08800119910434	ML 1200 600 Multi P D98 MHT Dark 28T
08800119910427	ML 1200 600 Multi P D98 MHT Dark 30T
08800119910410	ML 1200 600 Multi P D98 MHT Light 12T
08800119910403	ML 1200 600 Multi P D98 MHT Light 14T
08800119910397	ML 1200 600 Multi P D98 MHT Light 16T
08800119910380	ML 1200 600 Multi P D98 MHT Light 18T
08800119910373	ML 1200 600 Multi P D98 MHT Light 20T
08800119910366	ML 1200 600 Multi P D98 MHT Light 22T
08800119910359	ML 1200 600 Multi P D98 MHT Light 25T
08800119910342	ML 1200 600 Multi P D98 MHT Light 28T
08800119910335	ML 1200 600 Multi P D98 MHT Light 30T
08800119910328	ML 1200 600 Multi P D98 MHT Medium 12T
08800119910311	ML 1200 600 Multi P D98 MHT Medium 14T
08800119910304	ML 1200 600 Multi P D98 MHT Medium 16T
08800119910298	ML 1200 600 Multi P D98 MHT Medium 18T